BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 463202 · Received May 27, 2003

    Report

    Report Number
    MW1028549
    Event Type
    Injury
    Date Received
    May 27, 2003
    Date of Event
    May 11, 2003
    Report Date
    May 27, 2003
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR IS A TYPE I INSULIN-DEPENDENT DIABETIC, ON THE MEDTRONIC MINIMED INSULIN PUMP PARADIGM MODEL, MMT-50A. THIS PUMP IS RATED WATER RESISTANT FOR UP TO EIGHT FEET DEEP UNDERWATER AT SEA LEVEL FOR NO MORE THAN 24 HOURS. PT WENT WADING AND RESERVOIR WAS IN PLACE BEFORE GOING IN. PT WAS IN THE RIVER WALKING ON A SAND BAR FOR ABOUT THIRTY MINUTES, NO DEEPER THAN ONE OR TWO FEET. THE PUMP ITSELF PROBABLY DID NOT EVEN BECOME WET. WHEN THEY GOT BACK TO THE HOUSE ON THE RIVER, THEY WENT IN THE POOL, ABOUT 15 MINS. AFTER LEAVING THE RIVER AND PT WAS SWIMMING AROUND, NO DEEPER THAN FIVE FEET FOR ABOUT THIRTY MINUTES. WHEN PT GOT OUT AND WAS ABOUT TO BOLUS INJECT THROUGH INSULIN PUMP FOR SOME ICED TEA THEY WERE DRINKING, THEY FOUND IT HAD LEAKED WATER INTO THE PUMP, AND THE PUMP WAS OFF. PT COULD TELL THIS ONLY BY THE LACK OF THE MINIMED TEXT AT THE TOP AND THE AIR BUBBLES UNDER THE SCREEN, THE REST WAS WATER. PT CALLED MINIMED, TOLD THEM, AND REPORTED THE PUMP WAS GETTING WARM QUICKLY, SO PT TOOK OUT THE BATTERY WHICH WAS VERY HOT. THE PUMP WAS REPLACED RAPIDLY, AND PT WAS PLACED ON LONG-TERM INSULIN FOR THE THREE-DAY EXTENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED PARADIGM INSULIN PUMP -MMT-511NA- LZG MEDTRONIC MINIMED MMT-511NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Life Threatening| R